Intravascular catheter having an expandable incising portion and grating tool

ABSTRACT

An intravascular device is provided having an expandable portion including a plurality of struts capable of being moved between an open and a closed position. A grating tool is provided on at least one of the struts. The grating tool is configured to remove atherosclerotic material or other substances located within the blood vessel when the expandable portion is in the opened position and moved axially through the blood vessel.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a continuation-in-part of application Ser. No.15/200,767 filed Jul. 1, 2016, which is a continuation-in-part ofapplication Ser. No. 13/613,914 filed Sep. 13, 2012, which claims thebenefit of U.S. Provisional Application No. 61/534,018, filed Sep. 13,2011, the disclosures of all of which are incorporated herein byreference as if restated in their entirety.

BACKGROUND OF THE INVENTION

This invention relates in general to intravascular catheters, such ascan be used during minimally invasive surgical procedures. Inparticular, this invention relates to an intravascular catheter havingan expandable incising portion.

Atherosclerosis is a chronic condition in which atheromatous plaqueaccumulates on the inner walls of a blood vessel. As a result, the bloodvessel walls can become inflamed and, over time, may harden to formatherosclerotic lesions that cause a narrowing of the vessel lumen. Insevere cases, the atherosclerotic lesions can rupture and induce theformation of thrombus (i.e., blood clots), which can prevent blood flowthrough the narrowed vessel lumen.

There are known procedures and devices for treating or otherwisereducing the risks associated with atherosclerosis, such as angioplasty.However, in some cases it would be desirable to fragment theatherosclerotic lesions. Thus, it would be desirable to provide anintravascular catheter having an expandable portion that can beselectively controlled by a user and adapted to create incisions inatherosclerotic material to facilitate fragmentation of the materialduring an angioplasty procedure.

There are known procedures and devices for performing atherectomy byabrading atherosclerotic tissue through high speed rotational movement.Such devices include the Diamondback 360® by Cardiovascular Systems,Inc.¹ and the Rotablator™ by Boston Scientific™². These devices arecomplex, requiring high speed motors and control systems to operate themotors. In some cases, it would be desirable to remove atheroscleroticmaterial by grating or peeling it away through axial movement. Thus, itwould be desirable to provide an intravascular catheter having anexpandable portion and also having a grating tool surface for removingatherosclerotic material by forward and backward axial movement throughthe blood vessel. ¹http://www.csi360.com/products/coronary-diamondback-360-coronary-orbital-atherectomy-system-crowns/²http://www.bostonscientific.com/en-US/products/plaque-modification/rotablator-rotational-atherectomy-system.html

Embolism is a risk sometimes associated with surgical procedures such asthe treatment of peripheral artery disease. Plaque fragments, clots, orother particulate can become dislodged and travel through a patent'svascular system and cause damage. As such, embolic protection devicesare sometimes placed in the patient's vascular system during surgicalprocedures in order to catch and remove emboli that may form or becomedislodged. Use of such devices typically requires the selection,insertion, positioning, and removal of a separate device. Proper design,inventory maintenance, selection, placement, and removal can bedifficult, particularly in light of varying patient anatomy, conditions,and treatments being performed. Further, placed devices can becumbersome and difficult to work around. Thus, it would be desirable toprovide an intravascular catheter having an expandable portion and alsohaving an integrated embolic protection device.

SUMMARY OF THE INVENTION

This invention relates to an intravascular catheter device for useduring a surgical procedure. The catheter device includes a cathetertube having an expandable portion with a plurality of struts eachdefining an outer surface. The expandable portion is operable between aclosed position, wherein the expandable portion has a first diameter,and an opened position, wherein the expandable portion has a seconddiameter that is larger than the first diameter.

Grating tools may be integrated with the struts. In exemplaryembodiments, the grating tools may comprise slightly or partially raisedapertures, which may further comprise a sharpened portion. The gratingtools may be configured to grate or peel away atherosclerotic materialas the expandable portion is moved axially forwards and backwardsthrough the blood vessel. An incising element may also be provided onthe outer surface of one or more of the struts. The incising element maybe configured to fragment the atherosclerotic plaque.

An embolic protection device may be integrated with the expandableportion. In exemplary embodiments, the embolic protection device is amesh or film placed over a portion of the struts that is configured andpositioned to catch the atherosclerotic material being grated or peeledaway.

Various aspects of this invention will become apparent to those skilledin the art from the following detailed description of the preferredembodiments, when read in light of the accompanying drawings.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a plan view of a catheter device that includes a handleassembly and a catheter tube having an expandable incising portion, inaccordance with a first embodiment of this invention.

FIG. 2 is a cross-sectional side view of the handle assembly taken alongsection line 2-2 shown in FIG. 1 when the catheter device is in a firstoperating mode.

FIG. 3 is an enlarged cross-sectional side view of the catheter tubetaken along section line 3-3 shown in FIG. 1 illustrating the expandableincising portion disposed within a blood vessel.

FIG. 4 is a cross-sectional end view of the expandable incising portiontaken along section line 4-4 shown in FIG. 3.

FIG. 5 is a cross-sectional side view of the handle assembly taken alongsection line 2-2 shown in FIG. 1 when the catheter device is in a secondoperating mode.

FIG. 6 is an enlarged cross-sectional side view of the catheter tubetaken along section line 3-3 shown in FIG. 1 illustrating the expandableincising portion in an opened position.

FIG. 7 is a cross-sectional end view of the expandable incising portiontaken along section line 7-7 shown in FIG. 6.

FIG. 8 is an enlarged side view of a catheter tube having an expandableincising portion, in accordance with a second embodiment of thisinvention.

FIG. 9 is a side view of the catheter tube shown in FIG. 8 illustratingthe expandable incising portion in an opened position.

FIG. 10 is a cross-sectional end view of the expandable incising portiontaken along section line 10-10 shown in FIG. 9.

FIG. 11 is an enlarged side view of a catheter tube having an expandableincising portion, in accordance with a third embodiment of thisinvention.

FIG. 12 is a side view of the catheter tube shown in FIG. 11illustrating the expandable incising portion in an opened position.

FIG. 13 is an end view of the catheter tube as shown in FIG. 12.

FIG. 14 is an enlarged side view of a catheter tube having an expandableincising portion, in accordance with a fourth embodiment of thisinvention.

FIG. 15 is a side view of the catheter tube shown in FIG. 14illustrating the expandable incising portion in an opened position.

FIG. 16 is an end view of the catheter tube as shown in FIG. 15.

FIG. 17 is a side view of the device shown in FIG. 8 with an exemplaryembolic protection device installed thereon.

FIG. 18 is a side view of the device shown in FIG. 17 with theexpandable incising portion in the opened position.

FIG. 19 is a side view of the device shown in FIG. 11 with the exemplaryembolic protection device installed thereon.

FIG. 20 is a side view of the device shown in FIG. 19 with theexpandable incising portion in the opened position.

FIG. 21 is a side view of the device shown in FIG. 11 with anotherexemplary embolic protection device installed thereon.

FIG. 22 is a side view of the device shown in FIG. 21 with theexpandable incising portion in the opened position.

FIG. 23 is a side view of another exemplary embodiment of the device ofFIG. 8.

FIG. 24 is a side view of the device of FIG. 23 illustrated in an openedposition.

FIG. 25 is a side view of another exemplary embodiment of the device ofFIG. 11.

FIG. 26 is a side view of the device of FIG. 25 illustrated in an openedposition.

FIG. 27 is a side view of another exemplary embodiment of the device ofFIG. 14.

FIG. 28 is a side view of the device of FIG. 27 illustrated in an openedposition.

FIG. 29 is a side view of another exemplary embodiment of the device ofFIG. 8.

FIG. 30 is a side view of the device of FIG. 29.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

Referring now to the drawings, there is illustrated in FIG. 1 a catheterdevice, indicated generally at 10, in accordance with this invention.The illustrated catheter device 10 is configured to treat or reduce therisks associated with atherosclerosis. In general, the catheter device10 includes an expandable incising portion that can be inserted into ablood vessel and expanded to create incisions in atheroscleroticmaterial that has accumulated on inner walls of the blood vessel. Theincisions facilitate the fragmentation of the atherosclerotic materialduring a subsequent angioplasty or atherectomy procedure. Although thecatheter device 10 will be described and illustrated in the context oftreating atherosclerosis, it should be appreciated that the catheterdevice 10 can be used in any desired environment and for any desiredpurpose.

Referring now to FIGS. 1 and 2, the illustrated catheter device 10includes a handle assembly, indicated generally at 20. The illustratedhandle assembly 20 includes an elongated, cylindrical handle body 21.The handle body 21 may alternatively have any other shape that issuitable for easy handling by a surgeon. Further, the handle body 21 canbe made from any suitably rigid material including, but not limited to,stainless steel or polymers.

As shown in FIG. 2, the illustrated handle body 21 defines an internalchamber 22. A passage 23 extends into an end portion of the handle body21 for communication with the internal chamber 22. The handle body 21further includes a slot 24 that extends through a side wall thereof forcommunication with the internal chamber 22. The illustrated slot 24 mayhave any length or width as desired. As shown in FIG. 1, an indicator24A may be provided on the handle body 21 adjacent to the slot 24. Forexample, the indicator 24A can be a visual scale or any other indicatingmeans, the purpose of which will be explained below.

The illustrated handle assembly 20 also includes a control member 25that is supported on the handle body 21 for sliding movement within theslot 24. For example, the control member 25 is movable between a forwardposition (shown in FIG. 2), a rearward position (shown in FIG. 5), orany position therebetween, which will be further explained below. Asshown in FIG. 2, the illustrated control member 25 includes a baseportion 26 that is disposed within the internal chamber 22 of the handlebody 21. The base portion 26 may define an outer cross-sectional shapethat generally corresponds with a cross-sectional shape of the internalchamber 22, although such is not required. Alternatively, (or inaddition), the control member 25 may be movably supported on the handlebody 21 by a bearing, a bushing, a guide rail, or any other structuralmeans. In other embodiments, the control member 25 may be supported forrotational movement, pivotal movement, or any other type of movementrelative to the handle body 21, the purpose of which will becomeapparent below. The visual indicator 24A, described above, is configuredto identify the relative position of the control member 25 with respectto the handle body 21.

The illustrated handle assembly 20 also includes a locking mechanism 27that is configured to temporarily secure the control member 25 in adesired position, although such is not required. As shown in FIG. 2, theillustrated locking mechanism 27 includes a plurality of protrusionsthat are spaced apart from one another along an inner surface of theslot 24. The control member 25 frictionally engages the protrusions tohold the control member 25 in the desired position. Alternatively, thelocking mechanism 27 may be a threaded fastener, a pivotal latch, apush-button release, or any other mechanism that is configured to securethe control member 25 in a desired position.

Referring now to FIGS. 1 through 3, the illustrated catheter device 10also includes a catheter tube 30 that extends from the handle assembly20. The catheter tube 30 is an elongated, flexible member having aproximal end that is secured to the handle assembly 20 and a distal endthat extends therefrom. The catheter tube 30 can be made from anybiocompatible material including, but not limited to, polyvinyl,polyethylene, nitinol, or stainless steel. Further, the catheter tube 30can have any outer diameter, length, or wall thickness.

As shown in FIG. 2, the proximal end of the catheter tube 30 is securedto the handle body 21 and communicates with the internal cavity 22through the passage 23. The catheter tube 30 may be secured to thehandle body 21 using a flanged connection, a fused connection, anadhesive, a press-fit connection, a threaded connection, or any othersecuring means. Alternatively, the catheter tube 30 may be secured tothe handle body 21 using a connector or any other type of attachmentdevice.

As shown in FIGS. 1 and 3, an expandable portion 32 is provided on thedistal end of the catheter tube 30. The illustrated expandable portion32 is a cylindrical member having a longitudinal axis. The expandableportion 32 can be made from a generally resilient material that is ableto flex between various positions, such as polyvinyl, polyethylene,nitinol, or stainless steel. The expandable portion 32 can be secured tothe catheter tube 30 in any manner including, but not limited to, afused connection, an adhesive, a press-fit connection, a threadedconnection, or any other securing means. Alternatively, the expandableportion 32 can be integrally formed from the catheter tube 30. Further,the expandable portion 32 can have any outer diameter, length, or wallthickness.

The illustrated expandable portion 32 has a pair of struts 34A and 34B.The illustrated struts 34A and 34B are separated by a pair oflongitudinally extending slits 35A and 35B that extend through sidewalls of the expandable portion 32. As shown in FIG. 4, the slits 35Aand 35B are equally spaced apart from one another around thecircumference of the expandable portion 32 such that the struts 34A and34B have the same circumferential widths, although such is not required.The struts 34A and 34B may have any length, circumferential width, orcross-sectional shape as desired.

As shown in FIGS. 3 and 4, the illustrated expandable portion 32 alsoincludes a pair of incising elements 36 that are respectively providedalong outer surfaces of the struts 34A and 34B. The incising elements 36can be atherotomes or other incising members having arcuate shapedsharpened edges, for example, that are configured to create incisions inatherosclerotic material as will be explained below. The illustratedincising elements 36 extend parallel with the longitudinal axis of theexpandable portion 32 and outwardly in a radial direction therefrom. Theincising elements 36 are equally spaced apart from one another aroundthe circumference of the expandable portion 32. The expandable portion32 may, however, have any number or configuration of incising elements36 provided around the circumference thereof. Further, the incisingelements 36 can have any cross-sectional shape, longitudinal length, orheight and can be made from any suitable material including, but notlimited to, tempered steel, stainless steel, high carbon steel, orceramics. The incising elements 36 can be molded with the struts 34A and34B or may otherwise be secured thereto in any manner such as, forexample, using a welded or soldered connection, an adhesive, or anyother fastening means.

The distal end of the expandable portion 32 may optionally include a tipmember 38. The illustrated tip member 38 has a generally conical shapethat facilitates insertion of the catheter tube 30 within a blood vessel50 (see FIGS. 3 and 4) and subsequent travel therethrough. The tipmember 38 may, however, have any desired shape. An aperture may axiallyextend through the tip member 38, the purpose of which will be explainedbelow. The tip member 38 can be integrally formed with the expandableportion 32 or may be secured thereto, such as with an adhesive or thelike. Further, the tip member 38 can be made from any biocompatiblematerial including, but not limited to, polyvinyl, polyethylene,nitinol, stainless steel, or polyether block amide.

As shown in FIGS. 2 through 4, the illustrated catheter device 10 alsoincludes an inner sleeve 40, although such is not required. The innersleeve 40 is a flexible, tubular member that is supported for slidingmovement within the catheter tube 30, the purpose of which will beexplained below. The inner sleeve 40 can be made from any biocompatiblematerial including, but not limited to, polyvinyl, polyethylene,nitinol, stainless steel, or a woven material. Further, the inner sleeve40 can have any outer diameter, length, or wall thickness. The innersleeve 40 need not be a tubular member but may alternatively be a solidwire, a braided wire, or the like.

As shown in FIG. 2, a proximal end of the inner sleeve 40 extends fromthe catheter tube 30 and into the internal chamber 22 of the handle body21. The proximal end of the inner sleeve 40 is secured to the baseportion 26 of the control member 25 for sliding movement therewith, thepurpose of which will be explained below. The inner sleeve 40 can besecured to the base portion 26 by a flanged connection, a fusedconnection, an adhesive, a threaded connection, or any other securingmeans.

As shown in FIG. 3, the inner sleeve 40 extends through an entire lengthof the catheter tube 30. A distal end of the inner sleeve 40 that isopposite the handle assembly 20 is secured to the tip member 38, whichis in turn secured to the expandable portion 32. The inner sleeve 40 maybe secured to the tip member 38 in any manner including, but not limitedto, a fused connection, an adhesive, a fastener, or the like.

Referring back to FIGS. 1 and 2, the illustrated catheter device 10 alsoincludes a protective sheath 42 that is supported for sliding movementalong an outer surface of the catheter tube 30, although such is notrequired. The protective sheath 42 can be made from any biocompatiblematerial including, but not limited to, polyvinyl, polyethylene,nitinol, or stainless steel. Further, the protective sheath 42 can haveany outer diameter, length, or wall thickness. The purpose of theprotective sheath 42 will be explained below.

The illustrated protective sheath 42 includes a flange 44 thatfacilitates sliding movement of the protective sheath 42 relative to thecatheter tube 30. The illustrated flange 44 is an annular member that islocated at an end of the protective sheath 42 nearest the handleassembly 20. The flange 44 can be integrally formed with the protectivesheath 42 or may otherwise be secured thereto in any manner, such aswith an adhesive or the like. It should be appreciated that the flange44 can have any shape or may alternatively be configured in any mannerto accomplish the functions described herein and below.

The operation of the catheter device 10 will now be described withreference to FIGS. 1 through 7. Referring initially to FIGS. 1 through4, the catheter device 10 is illustrated in a first operating mode. Inthe first operating mode, the control member 25 on the handle assembly20 is located in the forward position relative to the handle body 21.The inner sleeve 40 fully extends into the catheter tube 30 such thatthe expandable portion 32 is in a closed position, as shown in FIGS. 3and 4. In the closed position, the struts 34A and 34B are generallyparallel with one another and with the inner sleeve 40. The slits 35Aand 35B (illustrated by the dashed lines in FIG. 3) remain in agenerally closed configuration. As such, the expandable portion 32defines an initial diameter D1, which is generally the same diameter asthe remaining length of the catheter tube 30. The initial diameter D1 ofthe expandable portion 32 may, however, be any desired dimension.

When the catheter device 10 is in the first operating mode, the distalend of the catheter tube 30 can be percutaneously inserted into a bloodvessel 50, as shown in FIGS. 3 and 4. The illustrated catheter tube 30is then advanced through the blood vessel 50 along a guide wire 52,which extends through the catheter device 10. For example, the guidewire 52 may fully extend through the inner sleeve 40, into the internalchamber 22 of the handle body 21, and exit a rear end of the handleassembly 20 (see FIG. 2). The catheter tube 30 is advanced along theguide wire 52 until the expandable portion 32 is positioned in anarrowed region of the blood vessel 50 caused by atheroscleroticmaterial 54. Alternatively, the catheter tube 30 can be inserted intothe blood vessel 50 and guided therethrough by a delivery catheter (notshown) or any other suitable procedure. During insertion and advancementof the catheter tube 30 through the blood vessel 50, the optionalprotective sheath 42 is preferably positioned over the expandableportion 32, thereby preventing the incising elements 36 from coming intocontact with inner walls of the blood vessel 50.

Once the expandable portion 32 is positioned in the narrowed region ofthe blood vessel 50, the incising elements 36 can be exposed by slidingthe protective sheath 42 back from the distal end of the catheter tube30, as indicated by the direction arrows in FIG. 3. The illustratedprotective sheath 42 can be moved in this manner by pulling the flange44 towards the handle assembly 20, which is indicated by the directionarrows in FIG. 2.

Referring now to FIGS. 5 through 7, the catheter device 10 isillustrated in a second operating mode. To achieve the second operatingmode, the control member 25 is moved from the forward position to therearward position, as indicated by the direction arrow in FIG. 5. As thecontrol member 25 is moved to the rearward position, the inner sleeve 40is drawn within the catheter tube 30 thereby reducing the relativelength of the inner sleeve 40 with respect to the catheter tube 30. Thedistal end of the inner sleeve 40 is attached to the tip member 38, asdescribed above, causing the expandable portion 32 to become axiallycompressed between the tip member 38 and the distal end of the cathetertube 30. As a result, the struts 34A and 34B bow or expand outwardly ina generally arcuate fashion thereby defining an opened position. In theopened position, the expandable portion 32 defines a second diameter D2that is larger than the initial diameter D1 when the expandable portion32 is in the closed position. As shown in FIG. 6, the incising elements36 are respectively positioned along the radially outer most surfaces ofthe struts 34A and 34B. Further, the outer most surfaces of the struts34A and 34B may define a generally flat portion along a length thereofin the opened position, the purpose of which will be explained below,although such is not required. It should be appreciated that the struts34A and 34B can have any lengths such that the expandable portion 32 canachieve a desired overall second diameter D2 in the opened position.

During operation of the catheter device 10, the second diameter D2 canbe increased or decreased by selective movement of the control member 25between the forward and rearward positions. For example, a larger seconddiameter D2 can be achieved by moving the control member 25 furthertowards the rearward position. Conversely, a smaller second diameter D2can be achieved by moving the control member 25 further towards theforward position. The visual indicator 24A can be used to identify theinstantaneous second diameter D2 of the expandable portion 32.Alternatively (or in addition), the struts 34A and 34B may be biased inthe opened position so as to automatically expand outwardly to thesecond diameter D2 when the protective sheath 42 is slid back from theexpandable portion 32. As such, sliding movement of the protectivesheath 42 relative to the struts 34A and 34B can be used to selectivelycontrol the second diameter D2. In this configuration, the inner sleeve40 and the movable components of the handle assembly 20 may not benecessary.

When the catheter device 10 is in the second operating mode, theexpandable portion 32 can be pulled along the guide wire 52 through thenarrowed region of the blood vessel 50. This can be accomplished bypulling on the handle assembly 20. In doing so, the incising elements 36engage the atherosclerotic material 54 and create longitudinal incisions56 therein. As shown in FIGS. 6 and 7, the outer surface area of thearcuate shaped struts 34A and 34B, which is adjacent to the incisingelement 36, is configured to ride along a surface of the atheroscleroticmaterial 54, thereby limiting the depth of the incisions 56 andpreventing the incising members 36 from cutting the walls of the bloodvessel 50. The expandable portion 32 can be moved any distance along theguide wire 52 to create incisions 56 having any desired length. Afterthe incisions 56 are made in the atherosclerotic material 54, thecatheter device 10 can be returned to the first operating mode (shown inFIGS. 1 through 4) by moving the control member 25 to the forwardposition. In doing so, the expandable portion 32 returns to the closedposition. The protective sheath 42 can be slid over the expandableportion 32 and the catheter tube 30 may be removed from the blood vessel50.

Alternatively, the catheter device 10 can be used to create additionalincisions 56 in the atherosclerotic material 54. For example, after thecatheter device 10 has been returned to the first operating mode, theexpandable portion 32 can be relocated within the narrowed region of theblood vessel 50. The catheter tube 30 can then be rotated within theblood vessel 50 by rotating the handle assembly 20 so as to align theincising elements 36 with other portions of the atherosclerotic material54. The previous steps can then be repeated any number of times to makemultiple passes through the narrowed region of the blood vessel 50 andcreate additional incisions in the atherosclerotic material 54.

Thus, it should be appreciated that the illustrated catheter device 10is advantageous in many respects. In one example, the second diameter D2of the expandable portion 32 can be selectively controlled by operationof the handle assembly 20 or by sliding movement of the protectivesheath 42. This enables the catheter device 10 to be adapted for use inblood vessels 50 of different sizes or varying diameters. In anotherexample, the illustrated catheter device 10 can apply varying magnitudesof radial forces to the atherosclerotic material 54 by controlling theamount of force being applied to the control member 25 on the handleassembly 20. This enables the catheter device 10 to generate sufficientradial force to create incisions 56 in atherosclerotic material 54 whilereducing the potential for tearing the walls of the blood vessel 50. Inyet another example, the catheter device 10 can be used to make anynumber of passes during a single procedure to make multiple incisions 56in atherosclerotic material 54 of varying lengths and shapes.

Referring now to FIGS. 8 through 10, there is illustrated a cathetertube 130 having an expandable portion 132, in accordance with a secondembodiment of this invention. The catheter tube 130 and the expandableportion 132 may include any structural features as described andillustrated above in the previous embodiment, although such is notrequired. Similar features have been numbered with common referencenumerals but have been increased by 100 (i.e., 110, 120, 130, etc.). Itshould be appreciated that similar features are structured similarly,operate similarly, and/or have the same function unless otherwiseindicated by the drawings or this specification.

For example, the catheter tube 130 may extend from a handle assembly(not shown) as described above in the first embodiment. The expandableportion 132 is provided on a distal end of the catheter tube 130 and mayinclude a tip member 138. The catheter tube 130 may also include aninner sleeve 140 and a protective sheath (not shown), which is alsodescribed above in the first embodiment.

In the illustrated embodiment, however, the expandable portion 132includes four struts 134A, 1348, 134C, and 134D that are respectivelyseparated by four longitudinally extending slits 135A, 1358, 135C, and135D. The illustrated struts 134A, 134B, 134C, and 134D each include anincising element 136, although such is not required. It should beappreciated that the expandable portion 132 may have any number orconfiguration of struts and incising elements as desired.

As shown in FIG. 8, the illustrated expandable portion 132 furtherincludes recessed portions 160 that respectively extend into the outersurfaces of the struts 134A, 1348, 134C, and 134D. For example, thestruts 134A, 1348, 134C, and 134D can be slightly bowed inwardly towardthe inner sleeve 140 when in the closed position or, alternatively, mayhave a reduced thickness along a central portion thereof to create therecessed portions 160. The illustrated incising elements 136 arerespectively disposed within the recessed portions 160. Thus, when thecatheter tube 130 is inserted into a blood vessel, as described above,the recessed portions 160 help to prevent the incising elements 136 fromcoming into contact with inner walls of the blood vessel. On the otherhand, when the expandable portion 132 is expanded to an opened position,as explained below, the incising elements 136 become exposed from therecessed portions 160. It should be appreciated that the recessedportions 160 can eliminate or reduce the need for the protective sheath(not shown). The guide wire 152 may extend through the entire device.

The expandable portion 132 can be operated between a closed position(shown in FIG. 8) and an opened position (shown in FIGS. 9 and 10) byselective movement of the inner sleeve 140 relative to the catheter tube130, as described above in the first embodiment. Alternatively (or inaddition), the struts 134A, 1348, 134C, and 134D can be biased in theopened position. In such an embodiment, the protective sheath (notshown) can be used to effect movement of the expandable portion 132between the closed position and the opened position.

Referring now to FIGS. 11 through 13, there is illustrated a cathetertube 230 having an expandable portion 232, in accordance with a thirdembodiment of this invention. The catheter tube 230 and the expandableportion 232 may include any structural features as described andillustrated above in the previous embodiments, although such is notrequired. Similar features have been numbered with common referencenumerals but have been increased by 200 (i.e., 210, 220, 230, etc.). Itshould be appreciated that similar features are structured similarly,operate similarly, and/or have the same function unless otherwiseindicated by the drawings or this specification.

For example, the catheter tube 230 may extend from a handle assembly(not shown) as described above in the first embodiment. The expandableportion 232 is provided on a distal end of the catheter tube 230 andincludes a pair of struts 234A and 234B that are separated by a pair oflongitudinally extending slits 235A and 235B. The catheter tube 230 mayalso include a tip member 238, an inner sleeve 240, and a protectivesheath (not shown), which is described above in the first embodiment.The guide wire 252 may extend through the entire device.

In the illustrated embodiment, however, the expandable portion 232includes a first pair of weakened regions 237A, 237B and a second pairof weakened regions 239A, 239B that are respectively located at oppositeends of the struts 234A and 234B. The illustrated weakened regions 237A,237B and 239A, 239B are formed by enlarged apertures that extend throughside walls of the expandable portion 232 that function as hinges. Theweakened regions 237A, 237B and 239A, 239B may help reduce the amount ofbending stress in the side walls of the expandable portion 232 when thestruts 234A and 234B are moved to an opened position. The struts 234Aand 234B may include any number or configuration of weakened regions.Further, it should be appreciated that any of the other embodiments inthis disclosure may also include weakened regions 237A, 237B and 239A,239B.

The illustrated struts 234A and 234B remain generally flat alongrespective lengths thereof in both a closed position (shown in FIG. 11)and an opened position (shown in FIGS. 12 and 13) so as to form an apex,although such a configuration is not required. The incising elements 236are provided along the generally flat portion of the respective struts234A and 234B. As such, the incising elements 236 may also function asstiffening members for increasing the strength of the struts 234A and234B. Further, this configuration can reduce the amount of stress in theconnection between the incising elements 236 and the struts 234A and234B, which may otherwise be caused by bowing of the struts 234A and234B.

As shown in FIG. 12, end portions of the incising elements 236 mayextend beyond the apex that is formed by each of the respective struts234A and 234B. This configuration can increase the effective height ofthe incising elements 236 when the expandable portion 232 is in theopened position. As such, the incising elements 236 may have a reducedheight when the expandable portion 232 is in the closed position, whichmay eliminate the need for the protective sheath (not shown).

The expandable portion 232 can be operated between the closed positionand the opened position by selective movement of the inner sleeve 240relative to the catheter tube 230, as described above in the firstembodiment. Alternatively (or in addition), the struts 234A and 234B canbe biased in the opened position. In such an embodiment, the protectivesheath (not shown) can be used to effect movement of the expandableportion 232 between the closed position and the opened position.

Referring now to FIGS. 14 through 16, there is illustrated a cathetertube 330 having an expandable portion 332, in accordance with a fourthembodiment of this invention. The catheter tube 330 and the expandableportion 332 may include any structural features as described andillustrated above in the previous embodiments, although such is notrequired. Similar features have been numbered with common referencenumerals but have been increased by 300 (i.e., 310, 320, 330, etc.). Itshould be appreciated that similar features are structured similarly,operate similarly, and/or have the same function unless otherwiseindicated by the drawings or this specification.

For example, the catheter tube 330 may extend from a handle assembly(not shown) as described above in the first embodiment. The expandableportion 332 is provided on a distal end of the catheter tube 330 and mayinclude a tip member 338. The catheter tube 330 may also include aninner sleeve 340 that is attached to the tip member 338 and a protectivesheath (not shown), which is also described above in the firstembodiment. The guide wire 352 may extend through the entire device.

In the illustrated embodiment, however, the expandable portion 332includes a pair of struts 334A and 334B that are supported thereon in acantilevered manner (i.e., not attached to one another or to the tipmember 338 at their distal ends), the purpose of which will be explainedbelow. The struts 334A and 334B are separated by a pair oflongitudinally extending slits 335A and 335B that extend from the end ofthe expandable portion 332. A pair of incising elements 336 isrespectively provided along outer surfaces of the struts 334A and 334B.It should be appreciated, however, that the expandable portion 332 mayhave any number or configuration of struts and incising elements asdesired.

As shown in FIGS. 15 and 16, the illustrated struts 334A and 334B aresupported on the expandable portion 332 so that they can be splayed openin a Y-shaped configuration. For example, the struts 334A and 334B canbe splayed open by drawing the inner sleeve 340 within the catheter tube330, as described above in the first embodiment. In doing so, the tipmember 338 slides along the inner surfaces of the struts 334A and 334Band pivots them outwardly. Alternatively (or in addition), the struts334A and 334B can be biased in the splayed open position. In such anembodiment, the protective sheath (not shown) can be used to effectmovement of the expandable portion 332 between a closed position and thesplayed open position.

The struts 334A and 334B remain generally flat along their respectivelengths in both a closed position (shown in FIG. 14) and the splayedopen position, although such is not required. As such, the incisingelements 336 may also function as stiffening members for increasing thestrength of the struts 334A and 334B. Further, this configuration canreduce the amount of stress in the connection between the incisingelements 336 and the struts 334A and 334B, which may otherwise be causedby bowing of the struts 334A and 334B.

As shown in FIG. 15, end portions of the incising elements 336 mayextend beyond the distal ends of the respective struts 334A and 334B.This configuration can increase the effective height of the incisingelements 336 when the expandable portion 332 is in the splayed openposition. As such, the incising elements 336 may have a reduced heightwhen the expandable portion 332 is in the closed position, which mayeliminate the need for the protective sheath (not shown).

FIGS. 17 and 18 illustrate another exemplary embodiment of the presentinvention. Specifically, FIG. 17 illustrates the device of FIG. 8 withan exemplary embolic protection device 90 installed thereon, while FIG.18 illustrates the device of FIG. 17 with the expandable portion 132 inthe opened position. The embolic protection device 90 may comprise abasket configured to trap emboli for subsequent removal from thetreatment site.

The basket may surround the outer surface of the struts 134A, 1348, and134C as well as cover the gaps between said struts 134A, 1348, and 134Cwhen the expandable portion 132 is in both the closed and the openedpositions. To accomplish this, the basket may be configured to stretchand deform or may comprise excess and/or overlapping material when theexpandable portion 132 is in the closed position that unfurls when theexpandable portion 132 is in the opened position.

The basket may also cover the front and/or rear of the expandableportion 132. However, in exemplary embodiments of the present invention,the basket may be open on the proximal end and attached, sealed, bonded,or otherwise adhered to the tip member 138 on the distal end. In thisway, the basket creates an opening on the proximal end, and issubstantially or partially sealed on the distal end by the combinationof the basket, guide wire 152, inner sleeve 140, and struts 134A, 1348,and 134C. As will be explained in greater detail herein, the basket maybe comprised of a woven material or otherwise comprise a plurality ofapertures along the side walls thereof. In exemplary embodiments of thepresent invention, these apertures may be configured to permit blood toflow therethrough while preventing emboli and other particulate over aspecified size from traveling therebeyond. In this way, the blood flow,and any emboli or other particulate contained therein, are forced toenter the basket's opening on the proximal end and leave only if thematter fits through the apertures provided in the sidewalls of thebasket.

In exemplary embodiments of the present invention, the basket iscomprised of a mesh. The mesh may be of any size, shape, orconfiguration. The mesh may be comprised of nitinol,polytetrafluoroethylene (PTFE), a metallic, a polymer, or the like andmay extend over any section or the entirety of the expandable portion132. The mesh may be woven such that the apertures are sized to permitblood (including, for example without limitation, healthy cells, plasma,and platelets) flow therethrough, while trapping emboli and otherparticulate larger than the apertures provided in the mesh.

The embolic protection device 90 may extend over some or all of theexpandable portion 132. In exemplary embodiments of the presentinvention, the embolic protection device 90 extends over substantiallythe distal half of the expandable portion 132 while the incisingelements 136 may extend over substantially the proximal half of theexpandable portion 132. Regardless, an expandable hoop 91 may be locatedon the outer surface of the expandable potion 132 and may assist insecuring and preserving the shape of the basket. The expandable hoop 91may be located at substantially the midline of the expandable portion132, though any location is contemplated. The expandable hoop 91 may becomprised of nitinol, PTFE, a metallic, a polymer, or the like and maybe configured to expand and collapse when the expandable portion ismoved between the opened and the closed positions.

The expandable hoop 91 may be configured to match the outer diameter ofthe expandable portion 132 when the expandable portion 132 is in boththe opened and the closed positions and may be configured to fit insidethe sheath 42 if one is being used. In exemplary embodiments of thepresent invention, the expandable hoop 91 may operate by a telescopingmechanism such that portions of the expandable hoop 91 slide atop oneanother. In other exemplary embodiments, the expandable hoop 91 may beconfigured to deform by elongating and reorienting at an increasedlateral angle such that the expandable hoop 91 may be placedsubstantially flush with the outer surface of the expandable portion132, when the expandable portion 132 is in the collapsed position and/oris forced inside the sheath 42.

The expandable hoop 91 may provide an attachment point for the basket.For example, but not to serve as a limitation, in embodiments where thebasket is the mesh or other woven material, the mesh may be woven aroundthe expandable hoop 91. In other exemplary embodiments, the basket maybe welded, soldered, adhered, or otherwise bonded to the expandable hoop91 and/or directly to the struts 134A, 1348, and 134C or other parts ofthe intravascular catheter device 10.

In exemplary methods utilizing the present invention, the expandableportion 132 may be placed in the closed position and positioneddownstream from the treatment area. The expandable portion 132 may beplaced in the opened position. The embolic protection device 90 may beautomatically deployed when the expandable portion 132 is placed in theopened position as the basket, and the optional expandable hoop 91 ifutilized, may expand when the struts 134A, 1348, and 134C are placed inthe opened position and collapse when the struts 134A, 1348, and 134Care placed in the closed position. However, in exemplary embodiments ofthe present invention, the expandable hoop 91 may be moved between theclosed and the opened positions independently of the expandable portion132. For example, but without limitation, the expandable hoop 91 may beconfigured to automatically expand when removed from the sheath 42.Regardless, the expandable portion 132 may next be retracted along someor all of the treatment area to facilitate fragmentation of theatherosclerotic plaque. The expandable portion 132 and the embolicprotection device 90 may then be placed in the closed position, therebytrapping any emboli caught in the basket during the procedure. Thisprocess may be repeated multiple times over the same treatment area orover multiple treatment areas.

Similarly, FIG. 19 illustrates the device of FIG. 11 with anotherexemplary embolic protection device 90 installed thereon, while FIG. 20illustrates the device of FIG. 19 with the expandable portion 232 in theopened position. The embolic protection device 90 may be similar to theone shown and described with respect to FIGS. 17 and 18, and may besimilarly operated.

FIGS. 21 and 22 illustrate another exemplary embodiment of the embolicprotection device 90. The basket of the embolic protection device 90 maybe a film or covering having a number of apertures 92 located therein.Any size, shape, number, and configuration of the apertures 92 arecontemplated. In exemplary embodiments of the present invention, thefilm or covering is comprised of PTFE, though any material iscontemplated. Similarly, the film or covering may be attached to theexpandable hoop 91, though such is not required. The embolic protectiondevice 90 may otherwise be similar to the one shown and described withrespect to FIGS. 17-20, and may be similarly operated.

It is notable that while the embolic protection device 90 is illustratedwith respect to the devices of FIGS. 8-9 and 11-12, it is contemplatedthat the embolic device 90 may be utilized with any of the embodimentsof the present invention as shown and/or described herein.

FIG. 23 through FIG. 30 illustrate a grating tool 144, 244, and 344located on the expandable portion 132, 232, and 332, respectively. Thegrating tool 144, 244, and 344 may be placed upon any number of thestruts 134A, 1348, and 134C (or 234A and 234B or 334A and 334B). Thegrating tool 144, 244, and 344 may extend along the entire strut, anupper, lower, distal, proximal, or other portion thereof. The gratingtool 144, 244, and 344 may be any kind of device configured to grate,shred, peel, file, shave, cut, or remove any structure or obstruction inthe blood vessel 50. In exemplary embodiments, the grating tool 144,244, and 344 may be configured to perform atherectomy on atheroscleroticmaterial 54 located in the blood vessel 50 by moving the expandableportion 132, 232, and 332 axially through the blood vessel 50. However,the grating tool 144, 244, and 344 may be configured specifically forany particular purpose.

In exemplary embodiments, the grating tool 144, 244, and 344 comprises anumber of grating apertures located along the struts 134A, 1348, and134C (or 234A and 234B or 334A and 334B). The grating apertures may besimilar to those used on a cheese grater or microplane, but sized andconfigured to fit on the struts 134A, 1348, and 134C (or 234A and 234Bor 334A and 334B) and grate a substance or obstruction located withinthe blood vessel 50. In exemplary embodiments, the substance orobstruction to be grated is atherosclerotic material 54. The gratingapertures may contain a first portion that is elevated or depressedrelative to a second portion such that the substance or obstruction isremoved when the grating tool 144, 244, and 344 is passed over thesurface of the substance or obstruction. For example, but not to serveas a limitation, the elevated or depressed portion may be an edge of thegrating aperture or may be a tab or other protrusion into the gratingaperture. In addition, or alternatively, the grating apertures maycomprise a sharpened or roughened portion that is configured to removeatherosclerotic material 54 when the grating tool 144, 244, and 344 ispassed over the surface thereof.

The grating apertures may be of any size or shape. For example, but notto serve as a limitation, the grating apertures may be circular, oval,square, rectangular, or the like. Further, the grating apertures may bespaced apart along the struts 134A, 1348, and 134C (or 234A and 234B or334A and 334B) randomly or in any pattern. In exemplary embodiments, thegrating apertures are formed by punching, stamping, drilling, orotherwise cutting them out of the otherwise solid struts 134A, 1348, and134C (or 234A and 234B or 334A and 334B). However, in other exemplaryembodiments, the grating apertures may be integrally formed with thestruts.

The grating tool 144, 244, and 344 may be configured such that gratingis performed when the expandable portion 132, 232, and 332 is movedaxially through the blood vessel 50 forwards or backwards. In exemplaryembodiments, this may be accomplished by alternating or otherwisevarying the location of the relatively elevated surface (i.e., the firstportion). Additionally, or in the alternative, this may be accomplishedby alternating or otherwise varying the location of the sharpened orroughened portion on the distal or proximal side of the grating apertureas appropriate.

In other exemplary embodiments, the grating tool 144, 244, and 344 maybe configured such that grating is performed only when the expandableportion 132, 232, and 332 is moved axially through the blood vessel 50in a particular direction. For example, but not to serve as alimitation, the grating tool 144, 244, and 344 may be configured tograte the atherosclerotic material 54 when the expandable portion 132,232, and 332 is retracted axially through the blood vessel 50, but isconfigured to not grate the atherosclerotic material 54 when theexpandable portion 132, 232, and 332 is advanced axially through theblood vessel 50. Similarly, the grating tool 144, 244, and 344 may beconfigured to grate the atherosclerotic material 54 when the expandableportion 132, 232, and 332 is advanced axially through the blood vessel50, but is configured to not grate the atherosclerotic material when theexpandable portion is retracted axially through the blood vessel 50.

In exemplary embodiments, this may be accomplished by providing therelatively elevated surface (i.e., the first portion) on the distal orproximal side of the grating aperture as appropriate. Additionally, orin the alternative, this may be accomplished by providing the sharpenedor roughened portion on the distal or proximal side of the gratingaperture as appropriate. For example, but not to serve as a limitation,to grate the atherosclerotic material 54 when the expandable portion132, 232, and 332 is retracted axially through the blood vessel 50, therelatively higher surface (i.e., the first portion) and/or the sharpenedor roughened portion may be provided on the distal portion of theapertures.

The grating tool 144, 244, and 344 may be located such that it contactsthe substance or obstruction to be grated when the expandable portion132, 232, and 332 is placed in the opened position. The grating tool144, 244, and 344 may be configured such that it does not contact theblood vessel 50 wall or the structure or obstruction to be grated whenthe expandable portion 132, 232, and 332 is in the closed position.Regardless, a protective sheath 42 may be utilized which is configuredto substantially surround and protect the grating tool 144, 244, and 344from contact with surrounding blood vessel 50 or structures orobstructions therein when the expandable portion 132, 232, and 332 is inthe closed position. The expandable portion 132, 232, and 332 may beadvanced to a zone of attention within the blood vessel 50 and movedinto the opened position such that the grating tool 144, 244, and 344contacts the surface of the atherosclerotic material 54. The expandableportion, 132, 232, and 332 may then by moved axially through the bloodvessel 50 to perform atherectomy.

The grating tool 144, 244, and 344 may be used with or without theincising elements 136, 236, and 336. In such embodiments, the incisingelements 136, 236, and 336 may extend into the atherosclerotic material54, scoring it and facilitating fragmentation of the atheroscleroticmaterial 54. Simultaneously, the grating tool 144, 244, and 344 may ridealong the surface of the atherosclerotic material 54, grating it andfacilitating its removal.

It is contemplated that the grating tool 144, 244, and 344 may be usedwith any of the embodiments shown or described herein. In exemplaryembodiments, such as but not limited to the one illustrated in FIG. 29and FIG. 30, the grating tool 144, 244, and 344 may be used incombination with the embolic protection device 90, with or without theincising elements 136, 236, and 336. In this way, the atheroscleroticmaterial 54 grated or otherwise removed by the grating tool 144, 244,and 344 may be captured by the embolic protection device 90 and removedfrom the blood vessel 50. In exemplary embodiments, the embolicprotection device 90 may be sized and configured to capture theatherosclerotic material 54 fragments that would be created based on thesize and type of the grating apertures or other grating tool 144, 244,and 344 used.

The use of the embolic protection device 90 with the grating tool 144,244, and 344 is not limited to the embodiment shown in FIG. 29 and FIG.30. It is contemplated that the grating tool 144, 244, and 344, theembolic protection device 90, and/or the incising elements 136, 236, and336 may be used with any of the embodiments shown and described herein.While the grating tool 144, 244, and 344 is often described as beingused to grate or otherwise remove atherosclerotic material 54, thosehaving skill in the arts will recognize that the grating tool 144, 244,and 344 may be used to grate or otherwise remove any structure orobstruction located in the blood vessel 50.

The principle and mode of operation of this invention have beenexplained and illustrated in its preferred embodiments. However, it mustbe understood that this invention may be practiced otherwise than asspecifically explained and illustrated without departing from its spiritor scope.

What is claimed is:
 1. An intravascular catheter device for treating azone of attention located within a blood vessel comprising: a flexiblecatheter tube; an expandable portion secured to a distal end of saidcatheter tube and comprising a plurality of struts each defining anoutward facing surface, the expandable portion being operable between aclosed position, wherein the expandable portion has a first diameter,and an opened position, wherein the expandable portion has a seconddiameter that is larger than the first diameter; and a grating toollocated on at least one of the struts.
 2. The intravascular catheterdevice of claim 1 wherein: the grating tool comprises a number ofgrating apertures.
 3. The intravascular catheter device of claim 2wherein: each grating aperture comprises a first portion that iselevated relative to a second portion thereof.
 4. The intravascularcatheter device of claim 2 wherein: the grating apertures comprise asharpened or roughened portion.
 5. The intravascular catheter device ofclaim 1 wherein: the grating tool is configured to perform atherectomy.6. The intravascular catheter device of claim 1 wherein: the gratingtool is configured to grate a substance when retracted axially throughthe blood vessel.
 7. The intravascular catheter device of claim 2wherein: the grating apertures extend over substantially the proximalhalf of the struts.
 8. The intravascular catheter device of claim 2wherein: the grating apertures extend over the majority of the struts.9. The intravascular catheter device of claim 1 further comprising: anincising member provided on and extending from the outward facingsurface of at least one of the struts, the incising member having asharpened edge located along an upper edge thereof wherein saidsharpened edge extends substantially in parallel with a longitudinalaxis of the expandable portion when the expandable portion is in theclosed position and is configured to score atherosclerotic material whenmoved axially through in the blood vessel.
 10. The intravascularcatheter device of claim 5 further comprising: an embolic protectiondevice located on and configured to surround at least a portion of theouter surface of the expandable portion when the expandable portion islocated in both the opened and the closed position.
 11. Theintravascular catheter device of claim 10 wherein: the embolicprotection device is configured to capture the fragments of theatherosclerotic material grated by the grating tool.
 12. Theintravascular catheter device of claim 11 wherein: the grating tool islocated on a distal portion of the expandable portion; and the embolicprotection device is located on a proximal portion of the expandableportion.
 13. The intravascular catheter device of claim 1 furthercomprising: a protective sheath configured to selectively surround theexpandable portion and the grating tool when the expandable portion isin the closed position.
 14. The intravascular catheter device of claim 1further comprising: a handle assembly, wherein the flexible cathetertube extends from the handle assembly; and an inner sleeve travelingthrough the flexible catheter tube and in communication with the handleassembly, wherein the inner sleeve is configured to move the expandableportion between the opened and the closed positions.
 15. Theintravascular catheter device of claim 14 further comprising: a tipmember connected to a distal end of the inner sleeve and configured tomove the expandable portion between the opened and the closed position.16. The intravascular catheter device of claim 15 wherein: the strutsare supported in a cantilevered fashion on the expandable portion so asto by splayed open by the tip member when the tip member is retracted.17. An intravascular catheter device for treating a zone of attentionlocated within a blood vessel comprising: a flexible catheter tube; anexpandable portion secured to a distal end of said catheter tube andcomprising a plurality of struts, the expandable portion being operablebetween a closed position, wherein the expandable portion has a firstdiameter, and an opened position, wherein the expandable portion has asecond diameter that is larger than the first diameter; a number ofgrating apertures located on at least one of the struts, wherein saidnumber of grating apertures are configured to remove atheroscleroticmaterial when the expandable portion is moved axially through the bloodvessel; and an embolic protection device located on the expandableportion and configured to catch the fragments of atheroscleroticmaterial removed by the grating apertures.
 18. The intravascularcatheter device of claim 17 wherein: the number of grating apertures areconfigured to grate the atherosclerotic material only when the device isretracted axially through the blood vessel.
 19. An intravascularcatheter device for treating a zone of attention located within a bloodvessel comprising: a handle assembly; a flexible catheter tube extendingfrom the handle assembly; an expandable portion secured to a distal endof said catheter tube and comprising a plurality of struts each definingan outward facing surface, the expandable portion being operable betweena closed position, wherein the expandable portion has a first diameter,and an opened position, wherein the expandable portion has a seconddiameter that is larger than the first diameter; an inner sleeve locatedwithin the flexible catheter tube and in communication with the handleassembly, wherein the inner sleeve is configured to move the expandableportion between the opened and the closed positions; a number of gratingapertures, each having a first portion that is elevated relative to asecond portion, wherein the grating apertures are located on the strutsand are configured to perform atherectomy at the zone of attention whenthe expandable portion is placed in the opened position and movedaxially through the blood vessel; and an incising member extending alongand from the axial midline of the outward facing surface of at least oneof the struts, wherein said incising member is configured to fragmentatherosclerotic material located in the zone of attention.
 20. Theintravascular catheter device of claim 19 wherein: the grating aperturesare positioned on the strut such that the direction of the first portionvaries.